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Results from phase III NATALEE trial of Kisqal (ribociclib) + endocrine therapy show sustained reduction of recurrence in HER+/HER2- early breast cancer – Novartis

Written by | 31 Dec 2024

Novartis announced results from an updated analysis of the pivotal Phase III NATALEE trial of Kisqal (ribociclib) that underscore the extended efficacy beyond the duration of treatment in… read more.

Longer term results from phase III ASC4FIRST trial with Scemblix (asciminib) showing superior major molecular response rates at week 96 – Novartis

Written by | 16 Dec 2024

Novartis announced positive, longer-term results from the pivotal Phase III ASC4FIRST trial with Scemblix (asciminib) showing superior major molecular response (MMR) rates at week 96 . The study… read more.

European Commission approves Kisqali (ribociclib) with an aromatase inhibitor for the adjuvant treatment of HR-positive, HER2-negative early breast cancer – Novartis

Written by | 13 Dec 2024

 Novartis announced that  the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive,… read more.

Novartis highlights transformative oncology research with 65+ abstracts at ASH and SABCS 2024

Written by | 26 Nov 2024

Novartis will present data from more than 65 abstracts, including investigator-initiated trials at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition and the 2024 San… read more.

NICE (UK) positive for Fabhalta (iptacopan) to treat paroxysmal nocturnal haemoglobinuria – Novartis

Written by | 20 Sep 2024

Iptacopan is recommended, within its marketing authorisation, as an option for treating paroxysmal nocturnal haemoglobinuria (PNH) in adults with haemolytic anaemia. Iptacopan is only recommended if the company… read more.

FDA accelerated approval for Fabhalta (iptacopan), the first and only complement inhibitor for the reduction of proteinuria in primary IgA nephropathy – Novartis

Written by | 14 Aug 2024

Novartis announced that the FDA has granted accelerated approval for Fabhalta (iptacopan), a first-in-class complement inhibitor for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy… read more.

Asciminib receives FDA priority review for newly diagnosed Ph+ CP-CML – Novartis

Written by | 9 Aug 2024

The FDA has granted priority review to asciminib (Scemblix) for the treatment of patients with newly diagnosed Philadelphia chromosome (Ph)–positive chronic myeloid leukemia (CML) in chronic phase (CP-CML)…. read more.

Lutathera is FDA approved as first medicine specifically for pediatric patients with gastro-enteropancreatic neuroendocrine tumors – Novartis

Written by | 27 Apr 2024

Novartis announced that the FDA approved Lutathera (USAN: lutetium Lu 177 dotatate / INN: lutetium (177Lu) oxodotreotide) for the treatment of pediatric patients 12 years and older with… read more.

Kesimpta (ofatumumab) six-year efficacy data show substantial benefits in recently diagnosed treatment-naïve people with relapsing multiple sclerosis – Novartis

Written by | 20 Apr 2024

Novartis announced new long-term data from the ALITHIOS open-label extension study showing that up to five years, patients treated earlier and continuously with Kesimpta (ofatumumab) had fewer disability… read more.

New data shows early addition of twice-yearly Leqvio (inclisiran) following maximally tolerated statin therapy significantly reduces LDL-C in ASCVD patients in real-world setting – Novartis

Written by | 12 Apr 2024

Novartis announced new data demonstrating the early addition of twice-yearly Leqvio (inclisiran) to maximally tolerated statin therapy, prior to guideline-recommended ezetimibe, in a real-world setting significantly reduced low-density… read more.

Fabhalta (iptacopan) receives positive CHMP opinion as first oral monotherapy for adult patients with paroxysmal nocturnal hemoglobinuria – Novartis

Written by | 27 Mar 2024

Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing… read more.

New data is presented at MDA meeting of Zolgensma (onasemnogene abeparvovec) from the SMART study for the treatment of spinal muscular atrophy – Novartis

Written by | 11 Mar 2024

Novartis presented new data that continue to support the clinical benefits of Zolgensma (onasemnogene abeparvovec), the only one-time gene therapy for the treatment of spinal muscular atrophy (SMA)…. read more.

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